Quality Assurance Specialist: GMP, CAPA & Audits

PLZ Corp; Coal City (IL); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Life Insurance

Short-Term Disability

401k match

Paid Time Off

Bonus program

Job summary

PLZ Corp is seeking a Quality Specialist to support quality systems in a GMP environment. The role involves investigations into deviations and customer complaints, CAPA execution, and ensuring regulatory compliance across audits.

Applicants should have 3–5 years in QA within pharmaceutical/regulated manufacturing, with a Bachelor’s degree in a science or engineering field and strong writing and communication skills. On-site manufacturing environment in the United States.

Qualifications

• Bachelor's degree in science, engineering, or related field.
• Experience in QA within regulated manufacturing environments.
• Strong communication and documentation skills.

Responsibilities

• Lead investigations for deviations, non-conformances, and customer complaints with root cause analysis and timely closure.
• Drive CAPA activities to ensure effective corrective actions.
• Support validation activities and maintain 21 CFR 211 compliance and ALCOA+ data integrity.
• Assist change control, SOP development, and batch record review for compliance.
• Act as SME during audits (internal, customer, ISO, FDA) and provide preparation support.
• Perform risk assessments and trend analysis to strengthen quality systems.

Skills

Communication

Teamwork

Technical writing

Public speaking

Root cause analysis

Data integrity

Regulatory reporting

Prioritization

ERP systems

Education

Bachelor's degree in science/engineering

Tools

SAP

Job description

PLZ Corp is seeking a Quality Specialist to support quality systems in a GMP environment. The role involves investigations into deviations and customer complaints, CAPA execution, and ensuring regulatory compliance across audits.

Applicants should have 3–5 years in QA within pharmaceutical/regulated manufacturing, with a Bachelor’s degree in a science or engineering field and strong writing and communication skills. On-site manufacturing environment in the United States.